Septazole Oral Suspension 100 ml

Septazole Oral Suspension 100 ml

Composition:

Active Ingredients:
Each 5 ml of suspension contains Sulfamethoxazole 200 mg and Trimethoprim 40 mg.
Excipients:
Purified water, flavorings, stabilizing agents, preservatives, sweetening agents (suspension base).

Product Description:

• Septazole is a combined antibacterial medication containing sulfamethoxazole and trimethoprim in a 5:1 ratio, formulated as a liquid oral suspension for pediatric and adult administration.
• Its mechanism of action relies on a sequential dual blockade of bacterial folic acid synthesis:
  Sulfamethoxazole inhibits the synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA).
  Trimethoprim potentiates the activity of sulfamethoxazole by inhibiting the enzyme dihydrofolate reductase, preventing the conversion of dihydrofolic acid to tetrahydrofolic acid (the active form required for bacterial cell division).
• The synergistic action of these components provides a bactericidal effect.
  Septazole is active against a wide range of Gram-positive and Gram-negative bacteria (including Escherichia coli, Klebsiella species, Proteus species, Salmonella species, Shigella species, Haemophilus influenzae, Streptococcus pneumoniae, Pneumocystis jirovecii), as well as certain protozoa (Toxoplasma gondii).
• It is not active against Pseudomonas aeruginosa, Treponema pallidum, Mycobacterium tuberculosis, or viruses.

Indications for Use:

• Treatment of infectious and inflammatory diseases caused by susceptible microorganisms:
• Respiratory Tract and ENT Infections: Acute bronchitis, otitis media, sinusitis, pneumonia (including Pneumocystis pneumonia).
• Genitourinary Infections: Pyelonephritis, cystitis, urethritis, prostatitis.
• Gastrointestinal Infections: Bacillary dysentery, gastroenteritis, typhoid fever, paratyphoid fever, cholera.
• Skin and Soft Tissue Infections: Wound infections, pyoderma, furunculosis.

Method of Administration and Dosage:

• Administered orally after meals with an adequate amount of water or liquid.
• Shake the bottle well before each use.
• Children (Standard Daily Dosage): Divided into 2 equal doses taken every 12 hours:
  6 months to 5 years: 2.5 ml to 5 ml twice daily.
  6 to 12 years: 5 ml to 10 ml twice daily.
• Adults and Children over 12 Years: 20 ml twice daily (every 12 hours).
• Treatment Duration: Typically 5 to 7 days, or as directed by a physician.

Contraindications:

• Known hypersensitivity or allergic reaction to sulfamethoxazole, trimethoprim, sulfonamides, or any product excipients.
• Severe hepatic parenchymal damage or severe liver failure.
• Severe renal impairment (creatinine clearance less than 15 mL/min) where plasma concentration monitoring is unavailable.
• Blood disorders (aplastic, B12-deficiency, or megaloblastic anemia, leukopenia, agranulocytosis).
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (risk of hemolysis).
• Infants under 2 months of age (due to the risk of kernicterus).
• Pregnancy and breastfeeding (lactation) period.

Precautions:

• Allergic Reactions: Discontinue treatment immediately at the first sign of skin rash, hives, or any other hypersensitivity reaction.
• Pulmonary Reactions: If cough or shortness of breath appears or worsens, evaluate the patient for pulmonary infiltrates or allergic alveolitis and consider discontinuing treatment.
• Fluid Intake: Maintain adequate hydration during therapy to prevent crystalluria and kidney stone formation.
• Sunlight Exposure: Avoid prolonged sun exposure and UV radiation due to the risk of photosensitivity.
• Use with Caution: In patients with folate deficiency, bronchial asthma, thyroid disorders, or elderly patients.

Adverse Reactions / Side Effects:

Gastrointestinal System: Nausea, vomiting, diarrhea, loss of appetite, abdominal discomfort; rarely, elevated liver enzymes, hepatitis, cholestatic jaundice, pancreatitis.

Hematopoietic System: Leukopenia, neutropenia, thrombocytopenia; rarely, agranulocytosis, megaloblastic or hemolytic anemia.

Nervous System: Headache, dizziness; rarely, apathy, depression, peripheral neuritis.

Urinary System: Crystalluria, blood in urine (hematuria), interstitial nephritis, elevated blood urea/creatinine levels.

Allergic Reactions: Skin itching, rash, hives, photosensitivity; very rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema.

Metabolic System: Hyperkalemia, hyponatremia, hypoglycemia.

Pregnancy and Lactation:

Strictly contraindicated during pregnancy and breastfeeding.
Breastfeeding must be discontinued if therapy is required during lactation.

Storage Conditions:

Store at a temperature not exceeding 30 °C in a dry place protected from direct sunlight.
Keep out of reach of children.

Packaging:

Cardboard box containing 1 bottle of 100 ml oral suspension and a measuring spoon or cup, along with a patient information leaflet.